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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES UNKNOWN

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W.L. GORE & ASSOCIATES UNKNOWN Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/05/2007
Event Type  Injury  
Manufacturer Narrative
Added medical history. (b)(6). Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: on (b)(6) 2006:(b)(6) clinic. (b)(6), md. Radiology ¿ ct abdomen/pelvis without contrast. Indication: hernia, incisional. Comparison: contrast enhanced ct abdomen/pelvis (b)(6) 2003. Findings: gallbladder surgically absent, interval roux-en-y gastric bypass. Two left adrenal masses. Simple cyst lower pole left kidney. [illegible] intermediate density mass projecting laterally from left kidney unchanged, likely hemorrhagic cyst. Three hernias are demonstrated in association with [illegible] anterior abdominal wall incision. The most superior of these hernias contains a short segment of colon and a short segment of the roux limb; the next most inferior hernia contains a portion of the roux limb and a short segment of small bowel; the most inferior hernia is very small and contains only fat. Abdomen/pelvis otherwise unremarkable. On (b)(6) 2006: (b)(6) clinic. (b)(6) md. Office notes. Seen at request of dr. (b)(6). History of present illness: (b)(6)-year-old male who underwent gastric bypass approximately 2 years ago; lost approximately 200 lbs. , still weighs approximately (b)(6) lbs. Postoperatively, developed upper abdominal wall hernia. No other previous abdominal operations except laparoscopic cholecystectomy years ago. Notes hernia increasing in size, becoming increasingly uncomfortable, particularly when up on his feet or sitting up in a chair. Current medications: neurontin, plavix [blood thinner], aspirin, lexapro, ativan, norflex, albuterol. Medical history: very long limb roux-en-y gastric bypass, type 2 diabetes, history of nephrotic syndrome, osteoarthritis, severe peripheral neuropathy, possible trans ischemic attack, depression. Abdomen: soft, obese, nontender, nondistended. Large upper midline ventral abdominal wall hernia; easily reducible. Impression: large ventral abdominal wall hernia after gastric bypass. Here for consideration of laparoscopic repair. Plan: excellent candidate; has had minimal other intra-abdominal operations and this is easily reducible. Hoping we can take down the adhesions; would hopefully minimize chance of recurrence. Would have to be off plavix approximately 2 weeks prior to operation; will stop tonight. Just seen by dr. (b)(6) regarding possible panniculectomy; turned down by insurance and will undergo further evaluation. Dr. (b)(6) feels would be beneficial to have hernia repaired prior to more consideration. On (b)(6) 2006:(b)(6) clinic (b)(6). (b)(6) md. Operative report. Preoperative diagnosis: ventral abdominal hernia, status postoperative gastric bypass. Preoperative indication: prevent complications. Assistant: [illegible], md; [illegible], md. Postoperative diagnosis: ventral abdominal hernia, status post gastric bypass. Procedure: laparoscopic ventral hernia repair. ¿the patient was brought to the operating room and placed under general endotracheal anesthesia. His abdomen was prepped and draped in the usual sterile fashion. A small horizontal incision was made on the right lateral abdominal wall at approximately the anterior axillary line. Dissection was carried down through the subcutaneous tissues using electrocautery. The fascia was divided over a short segment, the muscle was split, and the peritoneum was entered safely. A hasson trocar was placed and pneumoperitoneum established. Two 5-mm ports were placed on either side of the camera port under direct vision. There were extensive adhesions of omentum to the anterior abdominal wall in the upper midline. The patient obviously had a large hernia at the superior aspect of the incision but also had innumerable small hernias in a swiss cheese fashion going down through his entire midline incision down to his umbilicus. These adhesions were taken down off the abdominal wall with sharp dissection which took approximately two hours. Once the adhesiolysis had been completed, the extent of the hernia was marked out on the patient¿s abdominal wall after the pneumoperitoneum pressure had been reduced to 10 mmhg. The dimensions of the defect were larger than our largest piece of gore-tex mesh; therefore, we initially marked out the portion of the hernia that would be covered by our largest mesh. The mesh was trimmed to the appropriate shape, and 12 points were marked throughout its circumference for suture placement. Gore-tex sutures were placed at each of positions. The mesh was rolled up tightly and passed through the right lateral abdominal wall incision. Using a suture passer each of the gore-tex sutures was brought out through the abdominal wall surrounding the upper portion of the hernia. These were tied into position through separate stab incisions, and the tacker was used to tack the most superior aspect of the mesh in place giving us good apposition to the abdominal wall. This left us with approximately 15 cm of exposed swiss cheese-type hernia leading down to the umbilicus. A second gore-tex mesh was trimmed to the appropriate size giving us approximately 15 cm of overlap of the previously placed mesh as well as adequate overlap over the swiss cheese hernia. Gore-tex sutures were [illegible] again placed around its circumference. The mesh was rolled tightly and passed through the right lateral incision. The suture passer was once again used to bring the sutures out through the abdominal wall. One of the sutures was passed directly through the first mesh to attach the two pieces of mesh together. The tacker then was used around the entire circumference of both pieces of mesh as well as between the two pieces of mesh to give us good apposition. Pneumoperitoneum was released. All ports were removed under direct vision. The right lateral abdominal wall incision was closed in layers with 2-0 vicryl on the fascia and 4-0 vicryl subcuticular suture on skin. All of the stab incisions were closed with dermabond. Dressings were applied. ¿ wound type: type 1 ¿ clean. [nurse reviewer note: poor copy, difficult to read. ]. Product identification records for the alleged ¿gore-tex mesh¿ x 2 were not provided. On (b)(6) 2006:(b)(6) clinic (b)(6) hospital. (b)(6), md; (b)(6), md. Discharge summary. Reason for admission: ventral hernia status post gastric bypass. Postoperatively, developed upper abdominal wall hernia; has become increasingly uncomfortable. Current medications: vitamins c, b12, d, multivitamin, calcium carbonate. Plavix; last dose 2 weeks ago, lexapro, ativan, albuterol, gabapentin. Medical history: depression, diabetes, high blood pressure, colon polyp, other cancer, asthma, arthritis. Ct abdomen/pelvis (b)(6) 2006: three hernias demonstrated in association with healed anterior abdominal wall incision. Most superior hernia contains short segment of colon and short segment of roux limb; next most inferior hernia contains portion of roux limb and short segment of small bowel; most inferior hernia is very small. Hospital course: admitted (b)(6) 2006 to undergo laparoscopic repair of ventral hernia. Tolerated procedure well, admitted for observation. Postoperatively, course was uneventful; at time of discharge, incisions clean/dry/intact. Discharged tolerating oral intake, pain well controlled with oral medication, ambulating independently, voiding spontaneously. Resume home medications; new medications percocet, colace. Regular diet. See dr. (b)(6) in two weeks. On (b)(6) 2006:(b)(6) clinic. (b)(6), md. Radiology ¿ ct abdomen/pelvis without contrast. Indication: ventral hernia. Compared to (b)(6) 2006. Findings: since previous study, has been ventral hernia repair with mesh. There is a residual hernia superior to the mesh, containing a non-obstructed loop of the roux limb. Fluid underlying the ventral hernia mesh. Stable small left adrenal adenomas and renal cysts. Remainder negative. On (b)(6) 2007:(b)(6) clinic (b)(6). (b)(6), md; (b)(6), md. Operative report. Preoperative diagnosis: recurrent ventral hernia. Preoperative indication: recurrent ventral incisional hernia. Postoperative diagnosis: recurrent ventral incisional hernia. Procedure: laparoscopic ventral hernia repair with mesh. Graft/implant information: lot/serial #: (b)(4), catalog/model #: 1dlmc08, implant name: batch, dual mesh 1 m 26. 0x34, manufacturer: w. L. Gore co. , implant placement: not applicable. Anesthesia: general endotracheal tube anesthesia. Prep: betadine prep. ¿patient was first identified in the preoperative area. After indications, risks, benefits, and alternatives were discussed, patient agreed and wished to proceed. Patient was brought back to the operating room table and placed in the supine position. After induction of excellent general endotracheal anesthesia, the patient¿s arms were padded and placed in a 90-degree abducted position to his side. Patient¿s abdomen was then prepped and draped in the usual sterile fashion. After a surgical pause confirming the patient and the procedure, a 3-cm incision was made in the subcostal region at the midclavicular line on the right side. This was done sharply by scalpel, and then dissection was carried deeper bluntly with s-shaped retractors as well as electrocautery. The anterior and posterior abdominal walls were dissected out with electrocautery. The fascia was then incised sharply with a pair of scissors. The peritoneum was entered in an open fashion. A finger was inserted to confirm the intraperitoneal position. A 10-mm hasson trocar was then inserted into the abdominal cavity. Pneumoperitoneum was then successfully obtained. Two 5-mm ports were then inserted under direct visualization in the right lateral abdominal wall. Upon inserting the camera, we noticed a significant amount of intraperitoneal adhesions. These adhesions were from the omentum to the hernia sac. These adhesions were then carefully dissected sharply using a laparoscopic shears under direct visualization. Hemostasis was achieved with electrocautery. Once we had taken down all the adhesions, we localized the ventral hernia which was at the site of his previous gore-tex mesh repair. This was measured out to be approximately [illegible] cm. However, we wanted to get excellent coverage of the hernia and the old mesh for good fixation so we measured out an area of 22 x 32 cm for the mesh coverage. We decided to use a piece of gore-tex dual mesh measuring 26 x 34 cm and 1 mm thick. This was trimmed to size. We proceeded in the ventral hernia repair by placing eight gore-tex sutures evenly spread out around the edge of the gore-tex mesh approximately 1 cm in from the edge of the mesh and a suture approximately 1 cm wide. These sutures were all then tacked down to the mesh with a single throw. The mesh was then rolled up and inserted into the abdominal cavity. Using an endoscopic suture passer, the sutures were individually tacked up through the abdominal wall. We ensured that the rough edge of the mesh was approximated to the anterior abdominal wall, allowing the smooth gore-tex surface in contact with the bowel. Once all sutures were then pulled through the anterior abdominal wall, they were securely tied down to the anterior abdominal fascia. We then proceeded using an endoscopic tacker to tack all edges of the mesh to the anterior abdominal wall. We then proceeded in irrigating the abdominal cavity with a liter of warm saline which was then suctioned out using a suction irrigator. Upon the end of the procedure, there was a small amount of bleeding noticed within the surface of omentum that was removed from the hernia sac. A sponge was then inserted into the abdominal cavity through the trocar site and applied direct pressure to the bleeding sites. We did not see any active bleeding upon the end of the procedure. The sponges were then removed individually. All trocars were then removed under direct visualization. Pneumoperitoneum was released. A surgical count was performed to ensure that all needle, sponges, and equipment were accounted for at the end of the procedure. The 10-mm hasson trocar site was then closed at the fascial level with interrupted 2-0 vicryl sutures. All needle sites, puncture sites for the sutures, as well as the hasson trocar site were then closed with a running subcuticular 4-0 vicryl suture. These were then dressed with steri-strips and sterile band-aids. Patient was then placed in an abdominal binder for additional support. The patient tolerated procedure and was extubated in the operating room. A postoperative abdominal x-ray was then performed and reviewed by a member of the surgical team. ¿ wound type: type i ¿ clean. [nurse reviewer note: poor copy, difficult to read. ] the records confirm a gore® dualmesh® biomaterial (1dlmc08/04[illegible]68[illegible]09) was implanted during the procedure. On (b)(6) 2007:(b)(6) clinic. (b)(6), md. Radiology ¿ postoperative abdomen. Indication: status post laparoscopic ventral hernia repair. Findings: postoperative changes laparoscopic ventral hernia repair with multiple surgical tacks and clips in projecting over the [illegible] abdomen and pelvis. Negative for postoperative purposes. On (b)(6) 07:(b)(6) clinic (b)(6) hospital. (b)(6), md; (b)(6), md. Discharge summary. Reason for admission: (b)(6)-year-old male with recurrent midline ventral hernia. History roux-en-y gastric bypass in 2003. Subsequently operated on (b)(6) 2006 for a large ventral abdominal wall hernia; done as laparoscopic repair, two large pieces of gore-tex mesh used to cover the large defect. Did well following that surgery until (b)(6) 2006; got a bad respiratory infection. Following a severe coughing fit he noted a sudden onset of abdominal pain a felt a large tear in the upper portion of his abdomen. Following that he noticed an increasing bulge in that area. (b)(6) 2006 abdominal ct showed recurrence of ventral hernia at the superior margin as well as some folding over of the gore-tex mesh. Presents for surgical repair of recurring ventral abdominal wall hernia. Admission medications: plavix; last dose three weeks ago. Hospital course: on (b)(6) 2007, taken to operating room for repair of recurring ventral hernia; performed laparoscopically using gore-tex mesh to reinforce the recurrent superior defect. Tolerated procedure well. Started on fentanyl patient- controlled analgesia, iv fluid resuscitation, home medications and sliding scale insulin as needed. On (b)(6) complained of chest pain irradiating to both arms that worsened with palpation. Cardiac enzymes normal, ekg showed no changes; closely monitored and reported cessation of pain. At time of discharge, tolerating regular diet, ambulating and urinating without difficulty and pain controlled with oral pain medications. New medications: motrin, percocet, colace. General diet. Abstain from lifting more than 15 lbs. For next six weeks. Follow up dr. (b)(6) in 2 weeks. On (b)(6) 2007:(b)(6) clinic. (b)(6), md. Radiology ¿ ct abdomen/pelvis without contrast. Findings: postoperative hernia repair with mesh in anterior abdominal wall. There are at least two levels of mesh in a portion of the abdominal wall. There is some fluid just deep to both mesh repairs. There is nothing to suggest infection of the fluid collections. The more deep level of mesh is new since the ct scan (b)(6) 2006. No ventral hernia seen. Tiny stable left renal cyst. Abdomen/pelvis otherwise negative. On (b)(6) 2008: (b)(6) clinic. (b)(6), md. Radiology ¿ ct abdomen/pelvis without contrast. Indication: anemia, iron deficiency. Findings: nodularity left adrenal gland unchanged. Postoperative changes consistent with gastric bypass, cholecystectomy, hernia repair with mesh in anterior abdominal wall. The fluid collection deep to the mesh on prior ct resolved. Stable probable cyst mid left kidney. Probable second mass in lower pole of left kidney unchanged. Degenerative changes in spine, both hips. It should be noted that although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿possible reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence. ¿.
 
Event Description
It was reported to gore that the patient underwent an unknown type of hernia repair on (b)(6) 2006 whereby a gore® dualmesh® biomaterial was implanted. The complaint alleges that on (b)(6) 2007, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: "none provided". Additional event specific information was not provided.
 
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Brand NameUNKNOWN
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MEDICAL WOODY MOUNTAIN B/P
3750 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
jeff mcquerrey
9285263030
MDR Report Key9861156
MDR Text Key196606474
Report Number2017233-2020-00203
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 03/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/20/2020 Patient Sequence Number: 1
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